Registration Dossier

Administrative data

Description of key information

Reliable studies are available for CAS 68910-05-4 concerning skin and eye irritation. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report, acceptable for assessment
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Germany
- Weight at study initiation: 2.78, 2.63, 2.88, 2.80, 2.73, 2.56 kg
- Housing: individual, stainless steel cages without beddings
- Diet Ovator Solikanin, Muskator-Werke, Düsseldorf, Germany; 130 g /day
- Water Tap water 250 ml/day
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
6 (2 males, 4 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used:


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol 50% diluted in water
- Time after start of exposure: 4 hour


SCORING SYSTEM:
according to OECD Draize scores
Readings: 30-60 min, 24 h, 48 h, 72 h, 8 days after substance removal
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1-6
Time point:
other: 24,48,72 h
Score:
2.27
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
1-6
Time point:
other: 24,48,72 h
Score:
1.06
Max. score:
4
Reversibility:
not fully reversible within: 8 days

 

Readings

Animal

Exposure period: 4 h

Erythema

Edema

Additional findings

4 h

1

2

1

R:U/OE:U

2

2

1

R:U/OE:U

3

2

1

R:U/OE:U/HE

4

2

1

R:U/OE:U

5

2

2

R:U/OE:U/HE

6

1

0

R:U

24 h

1

2

1

R:U/OE:U

2

2

1

R:U/OE:U

3

4

2

N/OE:U

4

2

1

R:U/OE:U

5

2

1

R:U/OE:U/HE

6

1

0

R:U

48 h

1

2

1

HE

2

3

1

R:U/OE:U/HE

3

4

2

N

4

2

1

 

5

2

1

R:U/OE:U/HE

6

1

0

R:U

72 h

1

2

1

HE

2

3

2

HE

3

4

2

N

4

2

1

 

5

2

1

R:U/OE:U/HE

6

1

0

R:U

8 d

1

1

0

S/+

2

1

0

S/+

3

4

2

N:TI/+

4

1

0

S/+

5

4

1

N:OB/+

6

1

0

S/+

Mean

24, 48, 72 h

1

2

1

 

2

2.66

1.33

 

3

4

2

 

4

2

1

 

5

2

1

 

6

1

0

 

Mean 24, 48, 72 h

1-6

2.27

1.055

 

Symbols:

HE     haemorrhagia

N       necrosis

N:TI    necrosis (deep)

N:OB necrosis (superficial)

OE:U oedema exceeding beyond area of exposure

S        desquamation

+         pathologically confirmed

Interpretation of results:
corrosive
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report, acceptable for assessment
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Germany
- Weight at study initiation: 2.24, 2.77, 3.28 kg
- Housing: individual, stainless steel cages without beddings
- Diet Ovator Solikanin, Muskator-Werke, Düsseldorf, Germany; 130 g /day
- Water Tap water 250 ml/day
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): unchanged
Duration of treatment / exposure:
not applicable, because test substance remained in the eye and was not washed out
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none


SCORING SYSTEM: according to OECD Draize system
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
1-3
Time point:
other: 24.48,72 hrs
Score:
2.55
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: cornea area
Basis:
mean
Remarks:
1-3
Time point:
other: 24.48,72 hrs
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
1-3
Time point:
other: 24.48,72 hrs
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
1-6
Time point:
other: 24.48,72 hrs
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
1-3
Time point:
other: 24.48,72 hrs
Score:
2.89
Max. score:
3
Reversibility:
not reversible

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1 h

1

2

4

2

3

2

3

PC

2

2

4

2

3

3

2

PC

3

1

4

1

3

2

3

PC

24 h

1

2

4

2

3

3

3

E, PC

2

2

4

2

3

3

2

E, PC

3

2

4

2

3

2

2

E, Pv, Na

48 h

1

2

4

2

3

3

3

SI/Na

2

2

4

2

3

3

2

E, PC, Na

3

2

4

2

3

3

2

E, PC, Na

72 h

1

4

4

2

3

3

3

S1/Na

2

4

4

2

3

3

3

E, Na

3

3

4

2

3

3

3

E, Pv, Na

Mean

24 -72 h

1

2.66

4

2

3

3

3

 

2

2.66

4

2

3

3

2.33

 

3

2.33

4

2

3

2.66

2.33

 

Mean

24-72 h

1-3

2.55

4

2

3

2.89

2.55

 

 

Symbols:

S1: reading not possible due to pus formation

E: pus formation

PC: Pupil contracted

Na: scars at the eyelids

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

According to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the classification criteria for skin corrosion (cat. 1B) (H314: Causes severe skin burns and eye damage) are met.